510(k) clearance
Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
- 510(k) number
- K262214
- Applicant
- Guangzhou Aimooe Technology Co., Ltd.
- Decision date
- Oct 15, 2026
- Date received
- Jun 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HAW
- Device type
- Neurological Stereotaxic Instrument
- Device class
- Class II
- Regulation
- 21 CFR 882.4560
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Guangzhou, CN